Jul 30 2013
Stereotaxis, Inc. announced today that it has been granted 510(k) clearance by the Food and Drug Administration (FDA) to market its Vdrive™ Robotic Navigation System with V-Sono™ Intracardiac Echocardiography (ICE) catheter manipulator in the U.S. This represents the first FDA clearance for the Vdrive family of products, which has been utilized in Europe since 2011.
"This is an exciting milestone for Stereotaxis," said William Mills, Stereotaxis Board Chairman and Interim Chief Executive Officer. "The Vdrive platform has added significant clinical value to a growing number of Niobe® ES labs in Europe, and this V-Sono clearance should accelerate procedure growth in our U.S. installed base as well as open up an untapped, expanding electrophysiology (EP) market where ICE catheters are widely utilized.
"More than 68,000 ICE catheters are used in U.S. EP labs each year, a number that is growing at an annual rate of 15%," Mr. Mills added.
The Vdrive with V-Sono system is indicated for the remote control of compatible ICE (or ultrasound) catheters inserted into the right atrium. For a Niobe ES remote magnetic navigation procedure, the Vdrive with V-Sono system can improve efficiency by enabling a single-operator workflow through eliminating the need for manual ICE manipulation inside the sterile and radiation field. In addition, procedural outcomes can be improved with more precise, stable ultrasound imaging, and radiation exposure to the clinical team can be further reduced. Based on preliminary clinical input received, the Company believes that the Vdrive with V-Sono system can bring similar benefits to additional types of procedures (beyond Niobe) that utilize ICE catheters.
First released in Europe in 2011, the Vdrive system has been utilized in over 2,000 clinical cases to date, of which 100 have utilized the V-Sono disposable, which was launched in Europe in 2012. The Company's Vdrive with V-Loop™ circular catheter manipulator is undergoing a five-center Investigational Device Exemption (IDE) study as part of a 510(k) submission to the FDA. This 120-patient IDE study has completed 60% of enrollment.
Source: http://stereotaxis.com/